Fa'afefea ona siaki le moni o matapulepule fa'afoma'i

Talu ai o matapulepule faʻafomaʻi e resitalaina pe faʻatonutonuina e tusa ai ma masini faʻafomaʻi i le tele o atunuʻu poʻo itulagi, e mafai e tagata faʻatau ona faʻailoa atili i latou e ala i le resitalaina talafeagai ma faʻamatalaga faʻatonutonu. O se fa'ata'ita'iga lea o Saina, Amerika ma Europa.

Saina
O ufimata fa'afoma'i e aofia i le vasega lona lua o masini fa'afoma'i i Saina, o lo'o fa'amauina ma fa'afoeina e le matagaluega fa'atonutonu o vaila'au a le itumalo, ma e mafai fo'i ona fesiligia e masini fa'afoma'i e fesiligia ai le numera avanoa mo masini fa'afoma'i. O le so'oga o le:

http://www.nmpa.gov.cn/WS04/CL2590/.

Amerika Tele
O oloa matapulepule ua faʻamaonia e le US FDA e mafai ona fesiligia e ala i lana upega tafaʻilagi aloaia e siaki ai le numera o le tusi resitala, o le sootaga o:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

E le gata i lea, e tusa ai ma le POLICY lata mai a le FDA, o loʻo amanaʻia nei o se Mask of Chinese Standards i lalo o nisi tulaga, ma o le fesoʻotaʻiga o ana pisinisi faʻatagaina o:

https://www.fda.gov/media/136663/download.

Iuni a Europa
O le auina atu i fafo o ufimata faʻafomaʻi a le EU e mafai ona faia e ala i Faalapotopotoga Faʻasalalau faʻatagaina, lea o loʻo faʻatagaina e le Vaega Faʻasalalau e le EU Medical Device Directive 93/42/EEC (MDD) o:

https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=13.

Ole tuatusi ole su'esu'ega a le tino ua fa'atagaina e le EU Medical Device Regulation EU 2017/745 (MDR) o le:

https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34.